Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
The Indwelling Blood-Phase Hydrogen-Ion (pH) Analyzer is an anesthesiology device designed to continuously measure the pH of blood while remaining in contact with it within the vascular system, providing real-time acid-base status monitoring for critically ill patients. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBZ, regulated under 21 CFR 868.1170, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CBZ
- Device Class
- FDA class 2
- Regulation Number
- 868.1170
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Jun 20, 2002 | Substantially Equivalent | Terumo Cardiovascular Systems Corp. |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | Sep 23, 1997 | Substantially Equivalent | Diametrics Medical, Ltd. |
| K931112 | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | Jun 01, 1993 | Substantially Equivalent | Puritan Bennett Corp. |
| K920061 | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | Mar 30, 1992 | Substantially Equivalent | Abbott Laboratories |
| K912030 | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | Oct 30, 1991 | Substantially Equivalent | 3M Company |
| K912428 | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT | Aug 09, 1991 | Substantially Equivalent | Puritan Bennett Corp. |
| K884228 | CDI(R) 2000 BLOOD GAS MONITOR | Jan 30, 1989 | Substantially Equivalent | Cardiovascular Devices, Inc. |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Jun 25, 1986 | Substantially Equivalent | Vascular Technology Incorporated |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | Feb 02, 1981 | Substantially Equivalent | Biochem International, Inc. |
| K803014 | SENSOMAT | Dec 22, 1980 | Substantially Equivalent | Biochem International, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.